Clearance Summary
VASC-EZ received FDA 510(k) clearance under submission number K854428, sponsored by Barton-Carey Medical Products Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1986-02-13.
- Submission: K854428
- Applicant / Sponsor: Barton-Carey Medical Products Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 1986-02-13
Classification & Regulation
This clearance is catalogued under FDA product code DWL and 21 CFR 880.5780, within the General Hospital review panel as a Class II device.